Clinical Trials Logo

Clinical Trial Summary

The main objective of this study is to assess the effectiveness of low dose Vitamin K1 (200 micrograms per day) at improving anticoagulation control in unstable patients on warfarin. This study will also aim to look at effectiveness in the context of genes known to influence warfarin metabolism, variability in the consumption of Vitamin K rich foods, and patient knowledge about warfarin anticoagulation -- factors which have been associated with anticoagulation control and which can influence the effectiveness of this intervention in clinical practice.


Clinical Trial Description

A double-blinded placebo controlled pilot RCT assessing the effectiveness of daily supplementation with low dose Vitamin K1 (200 micrograms per day) against placebo at improving anticoagulation control. Previous studies assessing the efficacy of this intervention have been small and further trials are required to evaluate the true effectiveness and safety profile. Furthermore the impact of genetic polymorphisms, known to impact warfarin metabolism, on the effectiveness/safety of this intervention will also be assessed in this study. Demographic and clinical variables as well as potential confounding variables such as variable dietary Vitamin K intake, concomitant interacting medications, and anticoagulation knowledge will be assessed in this study. Given that this is a pilot study we will be looking at recruitment numbers and necessary parameter estimates to determine the number of patients available at our institution for the study. Power analysis will be performed to evaluate the treatment effect size between the placebo and intervention groups. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00794755
Study type Interventional
Source Ottawa Hospital Research Institute
Contact
Status Completed
Phase Phase 3
Start date November 2008
Completion date April 2010

See also
  Status Clinical Trial Phase
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT02239744 - Intervention Study on the Health Impact of Air Filters in Chinese Adults N/A
Completed NCT00143715 - Oral Vitamin K for Warfarin Associated Coagulopathy Phase 3
Not yet recruiting NCT05865691 - Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease
Recruiting NCT04377490 - Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy
Recruiting NCT04299828 - Evaluation of Pro-Inflammatory Leukocyte Activity in Patients Undergoing Cardiac Surgery
Withdrawn NCT01121510 - Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose Design 9 System Phase 1/Phase 2
Completed NCT04746391 - Impact of Clotting on Dialyzer Efficiency N/A
Completed NCT03820401 - Dialysis Performance of Different Dialyzer Membranes Using Different Coagulation Strategies N/A
Not yet recruiting NCT04744688 - Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment
Completed NCT05998421 - The Effects of Acupuncture on the Natural Pregnancy in Patients With Recurrent Abortion N/A
Terminated NCT00909298 - Left Ventricular Assist Device (LVAD) Specialized Centers of Clinically Orientated Research (SCCOR) Coagulation - Acute Intrinsic Pathway Antagonist (IPA) Phase 2
Completed NCT02339415 - Targeted Anticoagulation Therapy to Reduce Inflammation and Cellular Activation in Long-term HIV Disease Phase 2
Terminated NCT01428102 - RapidTEG MA Validation N/A
Completed NCT00990158 - Does Low Dose Oral Vitamin K Improve International Normalized Ratio (INR) Stability? Phase 3
Completed NCT00705991 - Validation of Thrombelastometry (ROTEM®) Phase 4
Completed NCT05166824 - Clinical Study To Assess The Safety, Parameters And Efficacy For Procedures Using A Radiofrequency Device N/A
Completed NCT03418363 - How DHEA Supplements Affect Coagulation in Women Using Birth Control Pills Phase 4
Completed NCT03139097 - Reference Range Study for the Quantra Analyzer With the Quantra Surgical Cartridge
Recruiting NCT05853796 - Observational Dutch Young Symptomatic StrokE studY - nEXT